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NCT00001895 · ClinicalTrials.gov registry record · Phase 3
Electromechanical Mapping to Evaluate Heart Muscle
A Phase 3 study of Myocardial Ischemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT00001895 is a Phase 3 study of Myocardial Ischemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 71 participants, below the 2,135-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001895, a Phase 3 study of Myocardial Ischemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment. When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop. Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
Conditions Studied
Interventions
- DRUG FDG
- DRUG NH(3)
Study Locations (1)
Maryland
- National Heart, Lung and Blood Institute (NHLBI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 1999-08 |
| Est. Completion | 2001-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001895
The ClinicalTrials.gov registry entry for NCT00001895 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,135-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (97% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myocardial Ischemia appearing as the primary indexed condition, and to 2 interventions - of which FDG is the first listed.
NCT00001895 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001895 about?
NCT00001895 is a clinical study titled "Electromechanical Mapping to Evaluate Heart Muscle". Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter...
What is the current status of trial NCT00001895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 1999-08. Estimated completion is 2001-12.
What conditions does trial NCT00001895 study?
This clinical trial studies the following conditions: Myocardial Ischemia.
What interventions are being tested in trial NCT00001895?
The interventions under investigation include: FDG (DRUG), NH(3) (DRUG).
Who is sponsoring clinical trial NCT00001895?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001895 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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